The National Agency for Food and Drug Administration and Control (NAFDAC) has disclosed the approval of 105 applications for the establishment of drug manufacturing facilities across the country amidst multinational pharmaceutical companies departing Nigeria.
These approved applications, chosen from a total of 143, adhere to the Good Manufacturing Practice (GMP) guidelines set by the World Health Organisation (WHO) and NAFDAC GMP for Medicinal Products Regulations 2021.
According to the Director General of NAFDAC, Mojisola Adeyeye, 35% of the approved facilities have completed construction and are progressing through the registration stages by NAFDAC’s guidelines for pharmaceutical plant establishment.
What you should know
Over 20 newly registered local drug manufacturers have collectively invested over $2 billion in erecting WHO-compliant facilities, representing a 12% increase in the number of active local manufacturers.
NAFDAC sees these local efforts as a positive step forward for Nigeria amid the departure of global pharmaceutical giants such as GlaxoSmithKline (GSK) and Sanofi.
Emzor Pharmaceuticals Industries Limited is set to commence commercial manufacturing of four antimalarial Active Pharmaceutical Ingredients (APIs) following technical collaboration with NAFDAC and Indian-based WHO prequalified API manufacturers partners, Mangalam Drugs and Organics Limited.
Additionally, six local manufacturers are planning to initiate the local manufacture of various classes of widely used APIs and pharmaceutical excipients.
NAFDAC is actively involved in capacity building through an international workshop on Local Manufacturing of Active Pharmaceutical Ingredients and Excipients.
The agency is preparing regulatory officers, manufacturers, students, and professors for a second workshop in the second quarter of 2024.
Swiss Pharma Nigeria Limited, one of Nigeria’s local manufacturers, recently had its pediatric formulation pre-qualified by the WHO, showcasing the growing global recognition of local products.
Other local drug producers and medical device manufacturers are also expressing interest in achieving global recognition.
Despite the challenges leading to the exit of multinational pharmaceutical companies, NAFDAC remains optimistic that with the right policies and regulatory environment, Nigeria can achieve self-sufficiency in the production of quality medicines that meet international standards.
The agency’s recent achievements, including attaining maturity three (ML3) status and WHO prequalification of the Central Drug Control Laboratory, signify efforts toward creating a stable and well-regulated manufacturing environment for essential medicines in Nigeria.
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